Free floating wedge suture anchor for soft tissue repair

ABSTRACT

A suture anchor device and method for attaching soft tissue to bone includes an anchor body and a suture locking wedge movably disposed within the anchor body. The suture locking wedge includes lateral portions which engage slots or windows in the anchor body. Tension applied to one limb of a suture causes the suture locking wedge to translate and rotate to a position which compresses the suture, thereby locking the suture in the anchor.

FIELD OF THE INVENTION

The present invention relates to an apparatus and method for repairingsoft tissue regions. More particularly, the present invention relates toan apparatus and method for adjustably affixing torn soft tissues to aregion of bone.

BACKGROUND

It is an increasingly common problem for tendons and other softconnective tissues to tear or to detach from associated bone. One typeof tear or detachment is a “rotator cuff” tear, wherein thesupraspinatus tendon separates from the humerus, causing pain and lossof ability to elevate and rotate the arm. Complete separation of tissuefrom the bone can occur if the shoulder is subjected to gross trauma,but typically, the tear begins as a small lesion, especially in olderpatients.

There are various surgical approaches for repair of the rotator cuff,one known as the “classic open” and another as the “mini-open”. Theclassic open approach requires a large incision and complete detachmentof the deltoid muscle from the acromion to facilitate exposure. The cuffis debrided to ensure suture attachment to viable tissue and to create areasonable edge approximation. In addition, the humeral head is abradedor notched at the proposed soft tissue to bone reattachment point, ashealing is enhanced on a raw bone surface. A series of small diameterholes, referred to as “transosseous tunnels”, are “punched” through thebone laterally from the abraded or notched surface to a point on theoutside surface of the greater tuberosity, commonly a distance of 2 to 3cm. Finally, the cuff is sutured and secured to the bone by pulling thesuture ends through the transosseous tunnels and tying them togetherusing the bone between two successive tunnels as a bridge, after whichthe deltoid muscle must be surgically reattached to the acromion.

The mini-open technique differs from the classic approach by workingthrough a smaller incision and splitting rather than detaching thedeltoid. Additionally, this procedure is typically performed inconjunction with arthroscopic acromial decompression. Once the deltoidis split, it is refracted to expose the rotator cuff tear. As before,the cuff is debrided, the humeral head is abraded, and the so-called“transosseous tunnels” are “punched” through the bone or suture anchorsare inserted. Following the suturing of the rotator cuff to the humeralhead, the split deltoid is surgically repaired.

Less invasive arthroscopic techniques continue to be developed in aneffort to address the shortcomings of open surgical repair. Workingthrough small trocar portals that minimize disruption of the deltoidmuscle, surgeons have been able to reattach the rotator cuff usingvarious suture anchor and suture configurations. The rotator cuff issutured intracorporeally and an anchor is driven into bone at a locationappropriate for repair. Rather than thread the suture throughtransosseous tunnels which are difficult or impossible to createarthroscopically using current techniques, the repair is completed bytying the cuff down against bone using the anchor and suture.

The skill level required to facilitate an entirely arthroscopic repairof the rotator cuff is fairly high. Intracorporeal suturing is clumsyand time consuming, and only the simplest stitch patterns can beutilized. Extracorporeal knot tying is somewhat less difficult, but thetightness of the knots is difficult to judge, and the tension cannotlater be adjusted. Also, because of the use of suture anchors to providea suture fixation point in the bone, the knots that secure the softtissues to the anchor by necessity leave the knot bundle on top of thesoft tissues. In the case of rotator cuff repair, this means that theknot bundle is left in the shoulder capsule where it can be felt by thepatient postoperatively when the patient exercises the shoulder joint.So, knots tied arthroscopically are difficult to achieve, impossible toadjust, and are located in less than optimal areas of the shoulder.Suture tension is also impossible to measure and adjust once the knothas been fixed.

There are various suture anchor designs available for use by anorthopedic surgeon for attachment of soft tissues to bone. A numberthese designs include use of a locking plug which is forced into acavity of the anchor body to secure the suture therein. Although thereis some merit to this approach for eliminating the need for knots in theattachment of sutures to bone, a problem with being able to properly setthe tension in the sutures exists. The user is required to pull on thesutures until appropriate tension is achieved, and then to set the plugportion into the suture anchor portion. This action increases thetension in the sutures, and may garrote the soft tissues or increase thetension in the sutures beyond the tensile strength of the material,breaking the sutures. In addition, the minimal surface area provided bythis anchor design for pinching or locking the sutures in place willabrade or damage the suture such that the suture's ability to resistload will be greatly compromised. Additionally, once the suture isfixed, the suture cannot be adjusted or retensioned. This is ashortcoming of such designs because it is not uncommon for a physicianto desire to reposition or adjust the tissue location and suture afterthe anchor has been set.

A suture anchor that addresses some of the shortcomings mentioned aboveis shown in FIGS. 1A and 1B. Anchor 1 may include a rotatable orpivoting cam 5 to lock suture 28 within suture anchor 1. Suture leg 28 amay be bound or connected to tissue (tissue not shown), and suture leg28 b may be free to be adjusted by the practitioner. In FIG. 1A, thebound suture tension (T1) is minimal as the tissue may not be adjacentthe anchor 1, and the practitioner is applying open suture tension (T2)to draw the suture 28 around the cam 5 and draw the tissue attached tobound suture leg 28 a closer to the suture anchor 1 and into engagementwith the bone. As the bound suture tension (T1) increases, due to thetissue being closer to its target location, T1 may begin to approximateor exceed the open suture tension (T2), and the resulting frictionalforce F_((T1+T2)) between the cam 5 and the suture 28 may cause the cam5 to rotate clockwise, and clamp down and lock or wedge the suture 28 asshown in FIG. 1B. Problematically, as the coefficient of frictionbetween the cam 5 and suture 28 decreases (such as, for example, in lowfriction environments when certain low friction sutures are used, and/orliquids present), the suture 28 may slip and cam 5 may not rotate or thelock force may not be sufficient, i.e. the lock mechanism may have atendency to fail. This is undesirable.

Other knotless suture anchors employ axially or translating wedges toactuate the suture lock. For example, U.S. Pat. Nos. 6,520,980 and6,585,730, both issued to Foerster describe locking wedges which move inan axial direction. The wedge is guided by anchor structures in an axialdirection. Frictional forces arise between the contacting surfaces.Consequently, the locking force on the suture is reduced by thefrictional forces arising between the wedge surface and the anchor body.It would be desirable to utilize the entire locking force of the wedgeto lock the suture without any frictional losses. Frictional lossesbetween the wedge and the anchor body are undesirable because more forceis required to lock and unlock the anchor.

Thus, a suture anchor device and method for repairing the rotator cuffor fixing other soft tissues to bone, wherein suture tension can beadjusted, released and conveniently retensioned after it is deployed andlocked, and that maintains a strong locking force and functions reliablyin a low friction environment is desirable.

It is also desirable that the suture anchor is adapted to lock andunlock the suture when tension is applied to a particular suture leg,and wherein all the force arising from the suture tension is directed tolocking and unlocking the suture without frictional losses.

It is also desirable that there is no requirement for the surgeon to tiea knot to attach the suture to the suture anchor, and wherein theprocedure associated with the new approach is better for the patient,saves time, is uncomplicated to use, and easily taught to practitionershaving skill in the art.

SUMMARY OF THE INVENTION

An anchor device for attaching soft tissue to bone with a suture wherethe suture is threaded through the anchor device and has a tissue limbof the suture and a free limb of the suture. The anchor device comprisesan anchor body wall defining a lumen through the anchor body. A suturelocking wedge is movably disposed at least partially within the lumen.The suture locking wedge is in contact with the suture when the sutureis threaded through the anchor device and looped around the suturelocking wedge such that when a tension force is applied to the tissuelimb of the suture, the suture locking wedge is urged into a firstposition in which the suture is compressed between the suture lockingwedge and a first contact location of the anchor body. When a secondtension force is applied to the free limb of the suture the suturelocking wedge is urged away from the first contact location such thatthe suture is not compressed.

In another embodiment, the suture locking wedge cooperates with theanchor body to move with a first degree of freedom and a second degreeof freedom with respect to the lumen. When a first tension force isapplied to the tissue limb of the suture the suture locking wedge isurged into a suture locking position in which the suture is compressedbetween the suture locking wedge and a first contact location of theanchor body. When a second tension force is applied to the free limb ofthe suture the suture locking wedge is urged away from the first contactlocation such that the suture is not compressed and can slide freelyaround the suture locking wedge.

In another embodiment, the first degree of freedom is rotation and thesecond degree of freedom is translation. The rotation may be about anaxis perpendicular to a longitudinal axis of the suture anchor device.The translation may be in a direction parallel to the longitudinal axis.

In another embodiment, the anchor device further comprises a gap betweenthe suture locking wedge and the lumen such that the suture lockingwedge remains substantially free floating when not in the suture lockingposition.

In another embodiment, the anchor body further comprises a bone fixationstructure for securing the anchor device in the bone wherein the bonefixation structure is selected from the group consisting of threads,ridges, barbs, and wings.

In another embodiment, the suture locking wedge comprises a first armand a second arm, the first arm having a different length than thesecond arm.

In another embodiment, an anchor device for attaching soft tissue tobone with a suture includes an anchor body comprising a lumen, whereininner walls which define the lumen comprise at least one window. Theanchor device also includes a suture locking wedge movably disposedwithin the lumen. The suture locking wedge is cooperatively engaged withthe window of the anchor body such that the suture locking wedge ismovable between a first position and a second position such that when atension force is applied to the tissue limb of the suture, the suturelocking wedge is urged into the first position in which the suture iscompressed between the suture locking wedge and a first contact locationof the body. When a second tension force is applied to the free limb ofthe suture the suture locking wedge is urged away from the first contactlocation such that the suture is not compressed.

In another embodiment, the suture locking wedge has at least oneextension member extending laterally from an edge of the suture lockingwedge and sized to interface with the window. The at least one extensionmember may comprise a plurality of pins.

In another embodiment, the suture locking wedge has two substantiallyplanar surfaces which contact the suture. In another embodiment, thesuture locking wedge has a uniform height or thickness. The suturelocking wedge may have a height that is less than or equal to ½ thediameter of the suture.

In another embodiment, the suture anchor has an elastic or deformableportion. The suture locking wedge may comprise an elastic section whichdeforms when the suture locking wedge is placed in the first position.In one embodiment the anchor body comprises a slit or cut allowingdeformation. The anchor device may further comprise a flexible tetherextending between the suture locking wedge and the body.

In another embodiment, the window comprises a plurality of regions. Theplurality of regions may include a first region corresponding to thesuture locking wedge in the first position and a second regionoverlapping with the first region and corresponding to the suturelocking wedge in the second position. The first region may have atrapezoidal shape.

The window may be covered or uncovered. In one embodiment, the widow isopen and uncovered.

In another embodiment, the first region comprises a first distal flatsection which forms a first suture locking wedge angle with a radialaxis of the anchor device, and the first suture locking wedge angleranges from 15 to 30 degrees.

In another embodiment, the second region comprises a second distal flatsection which forms a second suture locking wedge angle with the radialaxis of the anchor device, and the second suture locking wedge angleranges from 5 to 15 degrees less than the first suture locking wedgeangle. In another embodiment, the second suture locking wedge angle isabout 15 degrees.

In another embodiment, the suture locking wedge has a shape such thatwhen the suture locking wedge is urged into the first position, thesuture locking wedge compresses the suture at a second contact locationof the anchor body in addition to the first contact location. In oneembodiment, the first contact location and the second contact locationare on opposite walls of the lumen.

In another embodiment, the anchor device comprises only two discreteparts not including the suture.

In another embodiment, a method for securing soft tissue to bonecomprises: (a) securing a first limb of a length of suture to the softtissue to be attached to the bone; (b) extending the length of sutureinto an anchor body and looping the length of suture around a suturelocking member movably disposed within the anchor body and such that asecond limb of the suture extends from the anchor body; (c) fixing theanchor body within the bone; (d) applying a first tension on the secondlimb of the length of suture such that the length of suture slidesaround the suture locking member so as to move the first limb of thesuture and the soft tissue towards the anchor body and until a secondtension on the first limb of the suture arises from the soft tissue; and(e) releasing the second limb, thereby halting the application of thefirst tension on the second limb such that the second tension on thefirst limb of the suture causes the suture locking member to move fromthe unlocked position to the locked position, thereby compressing thelength of suture between the suture locking member and the anchor body.

The method may further comprise manually drawing on the first limb toincrease an amount of compression on the length of suture between thesuture locking member and the anchor body.

The method may further comprise releasing the suture from beingcompressed. Releasing may be performed by applying a third tension tothe second or free limb of the suture thereby causing the suture lockingmember to rotate and translate from the locked position to the unlockedposition. Additionally, after the step of releasing, the method mayfurther comprise retensioning the suture by drawing on the second orfree limb of the suture to reposition the soft tissue relative to theanchor body.

The method may further comprise locking or relocking the suture anchorby manually applying a fourth tension on the first or tissue bound limbof the suture to manipulate the suture locking member into the lockedposition

In another embodiment, a method for repairing soft connective tissuewith a suture comprises: (a) providing an anchor device, the anchordevice comprising an anchor body and a movable suture locking member atleast partially disposed within the anchor body, the suture lockingmember cooperatively engaged within the anchor body to move between alocked position in which a length of the suture is compressed between afirst contact surface of the suture locking member and the anchor body,and an unlocked position in which a gap is defined between the firstcontact surface of the suture locking member and the anchor body suchthat the length of suture is not substantially compressed between thesuture locking member and the anchor body; (b) securing a first limb ofthe suture to a first tissue section; (c) extending the length of suturein the anchor body and around the suture locking member such that asecond limb of the suture extends therefrom; (d) embedding the anchorbody in a second tissue section; (e) approximating the first tissuesection towards the second tissue section by applying a first tensionforce to the second limb of the suture so as to slide the length ofsuture around the suture locking member thereby creating a secondtension force on the first limb; and (f) adjusting the first tension tobe less than the second tension thereby causing the suture lockingmember to move until the suture locking member is seated in the suturelocking position, thereby compressing the length of suture. In oneembodiment, the step of adjusting the first tension to be less than thesecond tension causes the suture locking member to move by rotating andtranslating.

In another embodiment, the step of embedding the anchor body in a secondtissue section is performed by embedding the anchor body in a bone.

In another embodiment, the step of adjusting the first tension to beless than the second tension is performed by applying (or increasing)the second tension force to the first (or tissue) limb of the suture.The step of applying the second tension force to the first limb may beeffectuated by hand.

In another embodiment, the adjusting the first tension to be less thanthe second tension is effectuated by halting the applying a firsttension force to the second limb during the approximating step.

In another embodiment, a method for repairing tissue with a sutureanchor and a suture, comprises: (a) securing a tissue limb of the sutureto a first tissue section; (b) inserting a length of the suture into alumen of the suture anchor, and looping the length of the suture about asuture locking member movably disposed within the lumen of the sutureanchor such that a free limb of the suture exits the lumen proximal end;(c) inserting the suture anchor into a second tissue section; (d)applying a first tension on the free limb of the suture such that thelength of suture slides around the suture locking member, drawing thefirst tissue section towards the suture anchor until a second tension isapplied on the tissue limb of the suture from the first tissue section;and (e) halting the applying a first tension on the free limb while thesecond tension is applied on the tissue limb of the suture to cause thesuture locking member to move from a suture unlocked position to asuture locked position, compressing the suture between the suturelocking member and the suture anchor. In one embodiment, the halting theapplying a first tension on the free limb causes the suture lockingmember to move by rotating and translating.

In another embodiment, the rotating and translating the suture lockingmember seats the suture locking member in complimentary engagement withthe lumen of the suture anchor to compress the suture in the suturelocked position.

In another embodiment, a method for repairing soft tissue with a sutureanchor and a suture comprises: (a) fixing the suture anchor in a bone;(b) applying a first tension on the free first limb of the suture suchthat the length of suture slides around the suture locking member,drawing the soft tissue towards the suture anchor until a second tensionis applied on the second limb of the suture from the soft tissue; and(c) moving in two degrees of freedom the suture locking member from asuture unlocked position to a suture locked position, therebycompressing the suture between the suture locking member and the sutureanchor. In one embodiment, the moving is effectuated by pausing theapplying the first tension on the first limb of the suture while thesecond tension is applied on the second limb of the suture.

In another embodiment, the moving comprises moving in a translational,rotational, angular, non-linear direction, or combination thereof.

In another embodiment, the step of applying a first tension on the freefirst limb of the suture is carried out until the soft tissue is movedwithin a threshold distance from the anchor body, such that the secondtension arises on the second limb from the soft tissue. The thresholddistance may range from 2 to 8 mm. or, in some embodiments, from 3 to 6mm.

In another embodiment, a method for repairing a soft tissue comprises:(a) providing a plurality of anchor bodies each comprising a suturelocking wedge movably disposed therein, the plurality of anchor bodiesincluding a first anchor body and a last anchor body; (b) securing afirst limb of a length of suture to the first tissue section; (c)threading the length of suture through each anchor body of the pluralityof anchor bodies until the suture is looped around the suture lockingwedge of the last anchor body forming an intermediate limb of sutureextending into the last anchor body, and a free limb of suture extendingfrom the last anchor body, and such that a sequence of anchor bodies isdefined with the suture extending from the first anchor body to the lastanchor body; (d) fixing the plurality of anchor bodies in the softtissue such that the suture length extending between two sequentialanchor bodies spans the region; (e) decreasing the size of the region byapplying a first tension to the free limb of the suture so as to move atleast one of the first tissue section and second tissue section of softtissue towards the other tissue section; and (f) locking the suture inthe last anchor body by moving the suture locking wedge to a suturelocking position wherein the moving is effectuated by application of asecond tension on the intermediate limb of the suture.

In one embodiment, the region comprises a tear, and decreasing the sizeof the region comprises closing the tear. The soft tissue may comprisemeniscus.

In another embodiment, the step of providing a plurality of anchorbodies comprises providing at least 5 anchor bodies.

In another embodiment, the region does not comprise a tear and themethod comprises tightening or plicating the soft tissue. In anotherembodiment, the soft tissue comprises capsular tissue.

In another embodiment, moving the suture locking wedge is effectuated bypulling on the intermediate limb of the suture by hand.

In another embodiment, moving the suture locking wedge is effectuated byhalting applying the first tension to the free limb.

In another embodiment, the step of moving the suture locking wedgecomprises rotating an elongate locking arm extending from the suturelocking wedge to compress the length of suture between a first contactlocation of the suture locking wedge and the last anchor body.

In another embodiment, the step of moving the suture locking wedgecomprises rotating and translating the suture locking wedge.

In another embodiment, the step of moving the suture locking wedgecomprises moving the suture locking wedge in an angular andtranslational dimension to the first suture locking position.

In another embodiment, the step of moving the suture locking wedgecomprises loading the suture locking wedge in the first suture lockingposition with a biasing member in the last anchor body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show a partial cross section of a suture anchor having apinned cam, in an open and locked position respectively;

FIGS. 2A and 2B show a cross section of another suture anchor with afree floating suture locking wedge in an open and locked positionrespectively;

FIGS. 3A, 3B, and 3C show partial perspective, side, and top viewsrespectively of a suture anchor body prior to being deployed;

FIG. 3D shows a partial perspective view of a suture anchor including asuture locking wedge in an unlocked configuration;

FIGS. 3E-3G show enlarged views of various regions of a window in asuture anchor body;

FIGS. 4A-4C show partial side views of a suture anchor and a suturelocking wedge in an open, intermediate or transitory, and lockedconfiguration respectively;

FIG. 4D shows a diagram illustrating various forces on a suture lockingwedge arising from tension on a suture;

FIGS. 5A-5C show an insertion instrument loaded with a suture anchor,and the steps of inserting and anchoring the suture anchor in a bone;

FIGS. 6A and 6B show a suture anchor in rotator cuff tissue in an opensuture and locked suture configuration respectively;

FIGS. 7A-7C show another suture anchor including a suture locking wedge,an anchor body, and a trapezoidal shaped window therein;

FIGS. 8A-8D show another suture anchor including a suture locking wedge,an anchor body, and a multi-region window therein;

FIGS. 9A and 9B show another suture anchor including a suture lockingwedge, an anchor body, and a curved slot therein;

FIGS. 10A and 10B show another suture anchor including a suture lockingcam, an anchor body, and a nest or groove therein;

FIG. 11 illustrates a flow diagram of a method to secure connectivetissue to bone;

FIG. 12 is an illustration of a method for repairing a capsular tissue;and

FIG. 13 is an illustration of a method for repairing a meniscus.

DETAILED DESCRIPTION

Before the present invention is described in detail, it is to beunderstood that this invention is not limited to particular variationsset forth herein as various changes or modifications may be made to theinvention described and equivalents may be substituted without departingfrom the spirit and scope of the invention. As will be apparent to thoseof skill in the art upon reading this disclosure, each of the individualembodiments described and illustrated herein has discrete components andfeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments without departing fromthe scope or spirit of the present invention. In addition, manymodifications may be made to adapt a particular situation, material,composition of matter, process, process act(s) or step(s) to theobjective(s), spirit or scope of the present invention. All suchmodifications are intended to be within the scope of the claims madeherein.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents. Furthermore, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the invention. Also, it iscontemplated that any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present invention (in which case what is present hereinshall prevail).

The following co-pending patent applications, which are being submittedcontemporaneously with the present application, are incorporated byreference in their entirety: U.S. Ser. No. 13/359,631, entitled“ROTATING LOCKING MEMBER SUTURE ANCHOR AND METHOD FOR SOFT TISSUEREPAIR”; U.S. Ser. No. 13/359,673, entitled “RESTRICTED WEDGE SUTUREANCHOR AND METHOD FOR SOFT TISSUE REPAIR”; U.S. Ser. No. 13/359,826,entitled “BIASED WEDGE SUTURE ANCHOR AND METHOD FOR SOFT TISSUE REPAIR”;U.S. Ser. No. 13/359,891, entitled “METHOD FOR SOFT TISSUE REPAIR WITHFREE FLOATING SUTURE LOCKING MEMBER”, all of which are filed on the samedate as the present application, and all of which are commonly assignedto ArthroCare Corporation.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. It is also to be appreciated thatunless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs.

The present invention provides an improved knotless suture anchorapparatus for anchoring a length of suture with respect to a bonestructure. In an exemplary embodiment described herein, the apparatus isused to anchor a length of suture to the humeral bone of the humanshoulder. The length of suture is desirably looped through soft tissue,such as a rotator cuff tendon, to approximate and fix the soft tissuewith respect to the bone structure. It should be understood, however,that the suture anchor apparatus may be utilized to secure a length ofsuture to anatomies other than in a bone structure. In this regard, thepreferred apparatus includes an anchor body within which the length ofsuture may be adjusted freely and then anchored or secured withoutknots. If the anchor body is to be implanted within a body tissue,structure on the anchor's exterior may be provided for securing ittherein. In a preferred embodiment, the anchor body is inserted within abone structure, and a pair of wings are deployed from the exterior ofthe anchor body to hold it within the cavity.

As mentioned above, the present invention is particularly well-suitedfor repairing rotator cuff injuries by re-attaching the rotator cufftendon to the outside of the humeral head. Embodiments of the presentinvention permit minimally invasive surgeries on such injuries andgreatly facilitate rapid and secure fixation of the rotator cuff tendonto the humeral head. However, it should be understood that the sameprinciples described herein apply to the repair of other injuries inwhich soft tissue is to be re-attached to a bone structure or othertissue region.

Embodiments of the present invention permit the user to insert at leastone anchor into bone independently of any other anchor, lock an anchorin the bone, allow the user to subsequently tension or loosen a lengthof suture or wire between the anchors or between the anchor and softtissue, to affix the soft tissue, immobilize the suture or wire, releaseand retension the suture, and then disassociate the inserter assemblyfrom the at least one anchor, leaving the at least one anchor and thesoft tissue repaired. Such an anchor inserter assembly may preferablyeliminate the need to separately pass suture or wire, eliminate the needto tie knots, allow the procedure to be performed without the need tomove an arthroscope from an articular side to a bursal side of the cuff,and by virtue of the small diameter of the anchor implants, reduce thesize of the hole placed in any tissue, if passing the implant through.

Anchor Structure Overview

FIGS. 2A and 2B illustrate a suture anchor device 10 including a body 12which includes a cavity or lumen 24, and a second component, namely,suture locking wedge 42 which is positioned within the lumen 24 of theouter anchor body. The suture locking wedge 42 is adapted to movablycooperate with the anchor body 12 to lock and release a suture 28 bycompressing the suture between the anchor components. In particular,anchor body 12 includes a window or slot 45 which allows the suturelocking wedge to move from an unlocked open configuration to a lockedconfiguration as will be discussed in more detail herein.

In the embodiment shown in FIGS. 2A and 2B, the lumen 24 commences at aproximal aperture or opening 11, and extends distally along thelongitudinal axis of the anchor body 12. The axial lumen 24 is shown asbeing substantially cylindrical or tubular. However, the shape of thelumen or cavity may vary.

At least one suture 28 which includes at least one bound leg 28 a isshown threaded through the opening 11 and extends distally through thelumen 24, around the suture locking member or wedge 42, and maysubsequently be redirected proximally back through the lumen 24 and outof opening 11 to result in a free leg 28 b. The bound side or leg 28 ais considered bound because in practice, this leg, limb, or end of thesuture is “bound” to the soft or connective tissues to be attached tothe target tissue such as bone by virtue of passing the sutures throughthe connective or soft tissues using conventional suturing techniquesknown in the art. The free side or leg 28 b is considered “free” becausethe surgeon or practitioner, in practice, has control over this leg,limb, or end of the suture with his or her hands or appropriateinstrumentation.

Suture Locking Wedge

The suture locking wedge 42 is shown being movable within the lumen 24of the anchor body. The suture locking wedge 42 is free to movelinearly, angularly, and to rotate within the lumen. A window 45cooperates with lateral edges of the suture locking wedge 42 to allowmovement in multiple degrees of freedom yet maintain the suture lockingwedge within the lumen of the anchor. In a sense, the suture lockingwedge is free floating.

In a first or open configuration as shown in FIG. 2A, suture lockingwedge 42 is operable to allow suture free leg 28 b to be pulled so thatthe suture may slide freely around suture locking wedge 42 and into, outof, and through suture locking portion 40 so as to pull soft tissueattached to the bound leg 28 a closer to suture anchor 10. As the tissueis pulled closer to the anchor, a tension force arises on the tissuebound leg 28 a. Tension may also arise by the surgeon pulling on thetissue bound leg 28 a. Once a sufficient amount of tension is present onthe bound leg 28 a, the surgeon may adjust (e.g., release, reduce orhalt) the tension on the free limb 28 b so as to cause the suturelocking wedge 42 to translate and rotate, and to thereby lock the suture28 against a portion of the anchor body 12.

The shape of the suture locking wedge may vary. In FIG. 2A, the suturelocking wedge is shown as a simple plate 42 having two opposingsubstantially planar surfaces. The suture locking wedge need not haveone side or edge thicker than another. Indeed, the suture locking wedgemay have, but need not be limited to, a cuboid-like shape. Non-limitingexamples of cross sectional shapes of the suture locking wedge includesquare, rectangle, trapezoidal, oval, arcuate, triangular, andparallelogram.

Suture locking wedge 42 may preferably have a smooth surface, and morespecifically, a smooth distal surface to allow for easy suture slidingaround the suture locking wedge surface during use. Additionally, thesuture locking wedge 42 may have an elongate nest or groove (not shown)to provide some limitation to any lateral motion of the suture 28 (i.e.to keep the suture 28 from slipping off the suture locking wedge 42).The suture 28 itself may also preferably comprise a low frictionmaterial such as polyester suture to create an overall low frictionenvironment. Examples of sutures include without limitation low frictionUHMWPE suture and polyester suture.

The suture locking wedge may be formed of (or comprise) metal, polymer,or some other material. In a preferred embodiment, the wedge is formedfrom a riGid, relatively low friction material, so as to allow easysliding of the suture. Additionally, elastic or resilient materials orcomponents may be incorporated into the suture locking wedge and/or theanchor body. As the suture locking wedge is urged into a lockedconfiguration, the elastic component(s) may deform which can increasethe clamping force on the suture.

Windows and Slots

With reference to FIGS. 3A-3D, an anchor body 12 is shown having asubstantially cylindrical or tubular shape and two windows or slots 45.Preferably, but not necessarily, the windows or slots extend completelythrough the wall of the anchor. The windows and slots may be open orcovered. Construction of the windows or slots may be carried oututilizing various techniques including, for example, machiningPreferably, the anchor body is a metal such as stainless steel and theslots are laser cut.

The windows 45 allow the suture locking wedge 42 to freely rotate andtranslate yet prevent it from escaping from the tube. A tether or strap(not shown) may optionally be connected between the suture locking wedgeand the anchor body to prevent the suture locking wedge from exiting theanchor body. The tether may be made of a polymer or metal and serves tomaintain the wedge in the lumen. Such a redundancy is an addedsafeguard. Additional means for holding the suture locking wedge inposition or biasing the suture locking wedge are described in U.S. Ser.No. 13/359,826, filed Jan. 27, 2012, and entitled “Biased Wedge SutureAnchor and Method for Soft Tissue Repair”.

An enlarged view of a shape of an exemplary window 45 is shown in FIG.3E. The window 45 includes a plurality of overlapping regions 45 a, 45b. The regions correspond to certain positions of the suture lockingwedge to lock the suture, and to allow the suture to be drawn or pulled.

FIG. 3F shows region 45 a having a trapezoidal (or cap, hat-like) shape.It includes a horizontal portion 46 with respect to the longitudinalaxis (L) of the suture anchor. When in an open configuration, the suturelocking wedge rests on the horizontal portion 46 of the first region 45a.

Region 45 b is shown having a parallelogram-like shape. It also includesat least one substantially flat surface that forms an angle (a1) with aradial or central axis (C) of the suture anchor. Central axis C isperpendicular to the longitudinal axis (L). When the suture is put intension during locking, the suture locking wedge is manipulated towardsthis flat surface 47. Further details of the windows, their function,and suture locking are discussed below in connection with FIGS. 4A-4D.

Although not shown in this example, the anchor body 12 may compriseadditional openings or apertures. For example, apertures may providespace or room for suture routing. Suture routing, in some instances,requires the suture to be doubled up around a preloaded snare typedevice (not shown), and pulled through the anchor. More space at thelocations along the suture path where the suture turns is desirable. Tothis end, apertures are positioned at locations along the suture pathwhere the suture changes direction. The apertures are preferably sizedto be at least as wide as the suture diameter. However, the shape, sizeand location of the apertures may vary. When the anchor is loaded with asuture, for example, a portion of the suture 28 may protrude or rideoutside of the anchor body. Alternative embodiments may have additionalapertures elsewhere on the anchor body such as, for example, on theopposite or inferior side of the anchor body.

Additionally, with reference to FIG. 3C, at least one slit 48 or cut maybe added to the anchor body 12. For example, slit may be laser cut intothe body. The slit shown in FIG. 3C allows anchor body 12 to deform tosome degree when the suture locking wedge and suture are urged into asuture locking configuration as will be discussed in more detail below.Slit provides some elasticity to the anchor.

With reference to FIGS. 2A, 2B, the distal end section 30 of sutureanchor 10 may comprise a piercing tip 32 to penetrate soft tissue and bedriven into and through tissue and bone. The piercing tip may facilitatethe anchor to be pounded or driven into bone with a mallet orhammer-like instrument. Piercing tip 32 may be hollow or solid dependingon strength or weight requirements and manufacturing technique. Sutureanchor 10 may be preferably fabricated from a metal such as 316Lstainless steel, although other materials such as titanium may be used.Alternative embodiments may include a blunted tip for inserting into aprepared bone passage or a threaded or tissue cutting tip.

After the anchor is positioned within the target tissue, the anchor isfixed so as to remain in place. The suture anchor of the presentinvention may incorporate a number of features or structures to achievea bone lock including, for example, assuming a larger profile using avariety of anchoring means such as expansion ribs, molybolts, rivets,wings, and other mechanisms. Alternate embodiments may include athreaded, ridged or barbed portion on the outer surface 12 to lock intothe wall of the target tissue (not shown). In one embodiment, proximalend 20 may include an anchoring element with two deformable wings 22that may be permanently or reversibly deformed or outwardly deployableto have a larger profile so as to anchor or fix the suture anchor 10within the target tissue.

Suture Locking Detail

FIGS. 4A-4C are enlarged partial cross sectional views of a sutureanchor in an open, intermediate, and a suture locked configurationrespectively.

FIG. 4A shows suture locking wedge 42 in its loading position. Thesuture locking wedge 42 is shown on a horizontal surface, namely,surface 46 of window 45 to provide a position to hold wedge 42 in thesuture loading position. Suture loading or routing is often accomplishedby doubling the sutures around a pre-loaded snare and pulling the snarethrough the anchor. This can require double the space for sutures thanis required once the suture is snared. Consequently, a relatively largespace (or maximum space for a given size anchor outer diameter) isdesired between the suture locking wedge surfaces to contact the sutureand the walls of the anchor body.

The loading or open configuration allows the suture 28 to slide freelyaround suture locking wedge 42. A tension (T1) may be applied to suturefree end 28 b as locking member 42 remains in an open position such thatthe practitioner may slidingly draw suture 28 around suture lockingwedge 42. Consequently, tissue connected to the tissue side or bound leg28 a is positioned or approximated towards the anchor as desired.

As tension (T2) grows on suture leg 28 a due to tissue approximation,and the surgeon releases or modifies the tension on the free limb 28 b,the suture locking wedge 42 translates and rotates as shown in FIG. 4Buntil it reaches a final locking position shown in FIG. 4C. The sutureanchor design shown in FIGS. 4A-4C provides an area or region throughwhich the suture locking wedge moves as it transitions from a sutureloading position to the final suture locking position. The dual use ofthis area (i.e., for loading and locking) enables the suture lockinganchor to be small. Indeed, the height or thickness of the suturelocking wedge may be less than or equal to ½ the diameter of the suture.The anchor body may be sized correspondingly small, just large enough toaccommodate the suture locking wedge. This configuration thus enables arobust and small suture anchor.

FIG. 4C shows an enlarged partial cross sectional view of a sutureanchor wedge 42 in a locked position. In particular, suture lockingwedge 42 is shown positioned proximally, compressing suture 28 betweenedge surfaces of the locking wedge 42, and two suture contactingsurfaces 56, 58 of the inner wall 24 a, 24 b of the anchor body 12.

The suture locking wedge is manipulated into the locked position bydrawing on the suture legs. More specifically, a tension (T2) is createdon tissue bound end 28 a as tissue is approximated to the anchor. Aforce F_(T) in the axial direction is applied the suture locking wedge42 urging it proximally and against the locking surfaces 56, 58. ThoughFIG. 4C shows pinching the suture at two locations 56, 58, in otherembodiments, the suture may be pinched at fewer or more locations. Oneor more locations may be used to pinch or lock the suture with thewedge.

In addition to the translation force F_(T), a second type of force ormotion is applied to the suture locking wedge 42 when tension (T2)arises in the tissue bound suture leg 28 a. Because the suture lockingwedge is free to rotate, the suture locking wedge has at least a seconddegree of freedom (namely, it rotates in addition to translates). Arotation force F_(R) on the suture locking wedge 42 therefore arises.This force F_(R) urges the wedge in a counterclockwise direction, andacts to further compress the suture against the suture contactingsurfaces as the tissue bound suture leg is placed in tension. As will bediscussed in more detail herein, the locking or compression on thesuture increases as the tension T2 is increased because of thetranslation, and rotational forces placed on the suture locking wedge42.

Without being bound by theory, FIG. 4D is intended to illustrate some ofthe mechanical dynamics of a suture lock. As shown, a tension T in thetissue side of the suture loop 28 a supplies energy in the lock. Theenergy in the lock can be represented by normal forces at N1 and N2where (N1+N2)×coefficient of friction=lock force.

It can be seen that N1 and N2 vary with suture locking wedge angles a1and a2. As a2 increases, N1 and N2 decrease. As a2 decreases, N1 and N2increase.

At a2 equal to 30 degrees, N1 is estimated to be 173% of T and N2 isestimated to be 105% of T. At a1 equal to 15 degrees, N2 increases to126% of T. At this point, the lock is at nearly 300% of T. This meansthe suture will lock if the coefficient of friction is greater than ⅓.

Additionally, at a2 equal to 20 degrees and a1 equal to 15 degrees, thelock is at 535% of T and the suture will lock if the coefficient offriction is greater than about ⅕. Thus, as more and more tension isplaced on the lock; the walls of the tube will expand, the suture willcompress smaller, and the wedge will rotate to smaller angles enablingit to work even more efficiently.

It is noted that the frictional losses (e.g., frictional loss arisingfrom the suture being drawn around the wedge) has been omitted from theabove analysis. However, adding F(loss) would increase suture locking.The frictional properties of the materials involved can be changed byaltering surface roughness, treatments, and oxide content. As a1 and a2get smaller, the ability of the lock to function increases dramaticallytheoretically approaching infinity. The smaller angles also have abinding affect on the lock which can help the lock function in cyclicloading environments. In one embodiment a2 ranges from 15-30 degrees anda1 is 5-15 degrees less than a2.

Decreasing angles a1, a2, however, can also have adverse effects. Forexample, the sutures are harder to unlock by pulling on suture tails 28b as angles a1 and a2 become smaller. This is because unlocking isperformed by rotating wedge 42 around point 62. This is accomplished bypulling on suture tails 28 b and the friction between suture 28 andwedge 42 at 56 grabs the wedge and pulls it about point 62 on slot 45.As this rotation starts, point 62 on slot 45 can lift a little to letthe suture pass the other side of wedge 42 as well. The friction at 56increases as a2 gets larger making this unlocking dynamic easier.

Utilizing a combination of the above described parameters, the sutureanchor of the present invention moves the suture locking wedge from theopen loading position to a locked configuration. The anchor bodycooperates with the suture locking wedge to move the wedge with multipledegrees of freedom. Limiting the points of contact between the suturelocking wedge 42 and the window 45 (e.g., to only one point of contact62) enables most of the tension energy supplied by the suture to betranslated into the lock. Consequently, the suture locking wedge of thepresent invention can apply a greater clamping force than a standardplug or cam having only one degree of freedom. As discussed below, theanchor may be conveniently implanted, tensioned, locked, unlocked, andretensioned as desired.

Anchor Implantation Using Instrument

FIGS. 5A-5C illustrate a suture anchor being implanted. As shown, suture28 may be previously stitched, connected to or looped through tissue 102and preassembled within anchor 132 (e.g., routed through the anchorusing a snare) and instrument 128. The stitching process may beaccomplished by any known means, and any known suture stitch may beemployed. A stitch is desirably secured so that the suture is notinadvertently separated from the tendon after completion of the repairprocedure, necessitating re-entry to the surgical site. In preferredapproaches, the suture is attached to the soft tissue using a “mattressstitch,” which is well known in the art as being a particularly securestitch which is unlikely to fail postoperatively.

Anchor 132 may then be brought into contact against the underlying boneregion 100 using instrument handle 130. Now with reference to FIG. 5B,the proximal end of the instrument 128 or handle 130 may be tapped,e.g., by using a mallet, to drive the suture anchor 132 into the bone ata depth of, for example, approximately 6 mm. If viewed through anarthroscope, primary anchor 132 may be driven into the underlying bone100 until an anchor depth indicator 112, e.g., a colored marking orgradation is visible just above or at the bone 100 as a visual indicatorto the user that the appropriate depth for anchor insertion has beenreached. This may indicate that the anchor wings 164 have been insertedat the correct depth. Instrument 128 may also have lateral aperture oropening 140, located at the distal portion of the instrument butproximal to anchor wings 164, operable to allow passage of suture 28from tissue 102 into the anchor. Suture 28 may then extend distally fromaperture 140 within anchor 132, around a suture locking wedge (notshown) and return proximally within instrument (not shown here) and mayconnect with a portion of the instrument handle 130, operable formanaging the suture 28 during insertion and tensioning.

With suture anchor 132 suitably implanted, the anchor wings 164′ may bedeployed within the bone 100 using instrument 128, to lock the positionof anchor 132 and to prevent or inhibit anchor 132 from being pulled outof bone 100, as shown in FIG. 5C.

Anchor 132 may then be released from instrument 128, which may beachieved by a variety of mechanical means, operable to have a weaknessor failure point that fractures or disconnects upon application of aforce or torque. For example, instrument 128 may comprise a die ordriver 110 that moves relative to the anchoring structure 164 so as tourge the anchoring structure radially outwards. Some methods for thistype of release are described in U.S. Pat. No. 6,585,730, which ishereby incorporated by reference in its entirety. Also, it is to beunderstood that a wide variety of structures may be included with thesuture anchor to implant the anchor in bone including without limitationbarbs, ridges, threads, etc. Aspects of an instrument and methoddescribed in U.S. Patent Application Publication No. 2009/0069823 (whichis hereby incorporated by reference in its entirety) may be used toinsert and deploy anchor 132. Additionally, the anchor may be implantedin other manners, and without a sophisticated instrument as describedabove.

FIG. 6A shows a cross section of anchor 132 similar to the anchordescribed in FIG. 2. Anchor 132 is shown within bone tissue 267 and withanchoring structure 164′ deployed in the bone. The bone tissue 267 isthat of a shoulder 261, which comprises a humeral head 263, including anouter cortical bone layer 265, which is hard, and inner cancellous bone267, which is relatively soft. As is typically the case for rotator cuffinjuries, in this instance the supraspinatus tendon 251 has becomeseparated from the humeral head 263. It is desirable to reattach thetendon 251 to the humeral head 263. Alternate rotator cuff repairprocedures are also discussed in U.S. Pat. No. 6,524,317, and entitled“Method and Apparatus for Attaching Connective Tissues to Bone Using aKnotless Suture Anchoring Device”, which is hereby incorporated byreference in its entirety.

To effect the rotator cuff repair, the practitioner may first create anincision in the patient's shoulder 261, into which may be inserted atrocar 269, as shown in FIG. 6A. The trocar 269 permits access to theprocedural site for visualization instruments, as well as workinginstruments, and permits the procedure to be completed arthroscopically.Anchor 132 may then be connected with suture 28 and then insertedaccording to methods described herein. Insertion to the cortical layer267 is important to ensure anchoring structure 164′ gains good purchaseon the bone. Anchoring structure 164′ is deployed, at which point thedeployment instrument may be disconnected from the anchor 132 asdiscussed earlier and removed from the site.

With reference to FIG. 6A, suture locking wedge 142 is shown in an openposition, meaning that the suture free end 28 b may be freely tensionedor withdrawn proximally to draw tissue 251 to the correct location forreattachment to the bone. As discussed herein, the bound leg or legs 28a of the suture have been connected with the tissue or tendon 251 andmay extend through a lateral aperture 140 in the delivery instrument 128to gain access to the suture anchor 132, about the suture locking wedge142, until such time as the tendon 251 binding in the bound leg 28 a ofthe suture 28 creates a tension in the suture 28. This will occur whenthe tendon 251 has been drawn toward the anchor 132 as shown in FIG. 6B,and is itself under appropriate tension for an anatomically properrepair and otherwise snugly situated with respect thereto. Non-limitingexamples of threshold distances between the tissue 251 and the proximalend of the anchor range from 2-8 mm and more preferably 3-6 mm. Thesuture may be drawn by hand, by instrument, or a combination thereof.

Once the tension on the bound limb is present, the practitioner mayrelease or otherwise modify the tension on the free limb so as to allowthe tension in the suture bound leg 28 a to move the suture lockingwedge 142. In the embodiment shown in FIGS. 6A-6B, the suture lockingwedge translates, and then rotates within window 145 to the lockedposition as shown in FIG. 6B.

Reversibility

The suture locking mechanism of the present invention may be unlocked.It is reversible. Retensioning may be possible to permit the continuedadjustability of the bound end 28 a by applying tensile force to thefree end 28 b of the suture. This is useful as a surgeon will often findthat, during the course of a procedure, after the tendon/soft tissue 251has been brought into what is believed to be a desired position relativeto the bone to which it is being secured, and the suture 28 has beenlocked into place to retain the tendon in that orientation, a furtheradjustment is necessary or desired to optimize the outcome.

For example, after the free end 28 b has been pulled proximallysufficiently such that a tension is created in the bound end 28 a (dueto approximation of the tendon 251 to the bone 263), and the suture 28is locked by the suture locking wedge 142, the bound end 28 a isanchored in a fixed position. This ensures that the tendon is notmovable relative to the bone after completion of the procedure. However,if the practitioner requires the suture locking wedge to be unlocked,the practitioner may do so by applying sufficient tension on the freeend 28 b, (possibly also in combination with releasing tension on thebound legs 28 a) so as to permit adjustment of the size of the sutureloop through the tendon 251, which in turn permits adjustment or finetuning of the position of the tendon 251 with respect to the bone. Thepractitioner may make these adjustments by hand or using an instrument.

Once the tendon 251 is adjusted to the desired location, the suture 28may then be relocked as described above. The free end 28 b may betrimmed near the proximal end of the anchor portion 164′, and theincision is closed.

Repeated stress or use of the tendon after the surgery may tend to moveor dislodge the suture locking wedge. However, the increased clampingforce on the suture arising from the suture locking wedge havingmultiple degrees of freedom (and consequently increased leverage) servesto prevent dislodgement of the suture locking wedge. This is oneadvantage of the present invention even in low friction environments.

Alternative Embodiments

FIGS. 7A-7C show another suture anchor 300. The suture anchor shown inthis embodiment has an anchor body and a suture locking wedge 320movably disposed therein. The anchor body includes an internal lumen 310having a square cross section.

The suture locking wedge 320, which has a plate like shape, is held inthe anchor by a pair of trapezoid-shaped slots 308 present in the anchorbody. The suture locking wedge 320 has a lateral portion that extendswithin groove 308, and the motion of suture locking wedge 320 isrestricted or directed by the shape of the slot 308.

When the suture is placed in tension as described above, wedge 320translates and rotates proximally until it pinches the suture againstthe internal lumen 310 as shown in FIG. 7C. Suture 28 is shown in FIG.7C being pinched or compressed at locations 312 and 314.

The suture anchor 300 may be pounded into the bone and fixed thereinsimilar to that described above in connection with FIGS. 5A-5C. Inparticular, a driving component (not shown) may be releasably attachedto feature 350. The driving component may abut surface 352 to driveanchor 300 into the bone.

The anchor may include a sharp trocar tip 326 to pierce the bone. Wings342 and 344 are deflected by a die member of the instrument (not shown)and pivot at joints 346 and 348 respectively thus driving the wings intothe bone. Deflection of the wings into the bone fixes or secures thesuture anchor 300 in the bone. The suture may be snared and locked asdescribed above.

FIGS. 8A-8D show another suture anchor 400 having a suture locking wedge420 movably disposed in an internal lumen 404 of an anchor body 402. Thelumen is tubular, having a circular cross section.

The suture locking wedge 420 has lateral edges which engage a window 410in the anchor body 402. Similar to the suture anchors described above,the suture locking wedge 420 cooperates with the anchor body to allowsuture loading, and upon applying tension to the sutures, the wedge ismoved into the suture locking position which pinches the suture againstan internal surface of the suture anchor.

In the embodiment shown in FIGS. 8A-8D, the window comprises tworegions, namely, a rectangular-shaped first region 430 which allows thesuture to be loaded or snared, and a second pentagon-shaped region 440which allows the suture locking wedge to translate and rotate until thesuture is compressed against the internal lumen 404, thereby locking thesuture.

Though the suture anchor shares some features in common with thosedescribed above, the suture loading configuration 430 differs in thatthe window 430 has a nearly separate, discrete, deep pocket to containwedge 420 during snaring. This, in combination with aperture 460,provides sufficient space for suture snaring and routing.

The window 410 additionally includes stop feature 450. Stop feature 450provides additional stability for the wedge during suture routing.

The surface 470 has an angle of about zero degrees. As stated above inconnection with FIGS. 4A-4D, this increases the locking force. However,the invention is not so limited. The surface 470 may make other angleswith the radial plane.

FIGS. 9A and 9B illustrate another suture anchor 500 including a suturelocking wedge 520 having multiple degrees of freedom. The suture anchoris shown in an open or unlocked configuration in FIG. 9A, and a suturelocked position in FIG. 9B.

With reference to FIG. 9A, the anchor body 510 includes a slot 545 whichguides the movement of the wedge 520 along a curved or arcuate path. Thewedge engages the slot with a pin 522. Pin 522 is shown extendinglaterally from the edge of suture locking wedge 520. The pin preferablydoes not protrude beyond the exterior surface of the anchor body.

In the unlocked or open position shown in FIG. 9A, the suture lockingwedge 520 may be held in a near horizontal position. As described above,holding the suture locking wedge in a substantially horizontal orlateral position, in combination with maintaining a large gap or spacefor the suture to be routed, is desirable. Additionally, although notshown, the anchor body wall 510 may have apertures to provide additionalspace for the suture to be routed around the suture locking wedge.Portions of the suture may reside outside or outboard of the anchorbody. Therefore, the suture need not be confined to the lumen as it isrouted around the suture locking wedge.

After the suture anchor is loaded with the suture, or snared, and atissue is attached to the leg 28 a as described above, suture 28 b isdrawn. As the tissue becomes properly situated with the respect to theanchor and the relative anatomy, a tension force is applied to thesuture locking wedge 520.

As the suture applies a force to the suture locking wedge, the suturelocking wedge translates axially, and moves angularly along the arcuatepath defined by the slot 545. Additionally, because the suture lockingwedge is held by only one pin 522, suture locking wedge is free to pivotand rotate about the pin axis. Consequently, the suture locking wedgetranslates, moves angularly, and rotates to compress the suture againsta suture contacting surface 524 of the body 510.

In this embodiment the suture contacting surface 524 is shown beingnonparallel to the axis of the lumen. However, the suture contactingsurface can be any angle from the axis that is suitable for the degreeof locking desired.

Additionally, the combination of the types of motions increases thesuture locking force. The reduced number of contact points between thesuture locking wedge and the anchor body allows more of the suturecompressing force arising from tension on the suture to be directed tocompressing the suture and not lost on friction between the anchorcomponents. Additional suture anchor designs having guided wedges aredescribed in U.S. Ser. No. 13/359,673, filed Jan. 27, 2012, and entitled“Restricted Wedge Suture Anchor and Method for Soft Tissue Repair”.

FIGS. 10A and 10B show an isometric view and a cross sectional view of asuture anchor 700 respectively. The suture anchor 700 includes a suturelocking portion 701 having a floating suture locking member 706.

The suture locking member 706, which has a cam shape, is held in theanchor by a pair of slots, nests or grooves 705 present in the anchorbody. In particular, the cam 706 has a lateral portion that extendswithin groove 705, and the motion of cam 706 is restricted or directedby the shape of the groove 705. A second, mirror image nest (not shown)may be disposed on the opposite lateral side of anchor 700 so that asecond portion or opposite lateral side or edge of the floating cam 706may preferably be contained within this second nest.

As described in more detail below, the cam 706 is subjected to multipledegrees of freedom including a translational and rotational component asit moves from the open configuration to the locked configuration.

The floating cam 706 is shown in the open position in FIG. 10B, allowinga suture free end 28 b to be pulled freely through the suture anchor700. The cam 706 has a locking arm 708 and torque arm 709, disposedapproximately on opposite sides of the intrinsic pivot point of the cam706. The relative dimensions and angles of the locking arm and torquearm allow the torque arm to have a larger moment arm than the lockingarm. (e.g., the torque arm 709 is longer than the locking arm 706).Therefore once tension from the bound end 28 a reaches a sufficientlevel, calculate-able according to the relative moment arms between thetwo arms, the floating cam 706 may preferably move in a predominantclockwise direction to lock suture 28 within suture anchor 700; thelocking surface 707 being an inferior side. Additional suture anchordesigns having torque arms and cams are described in U.S. Ser. No.13/359,631, filed Jan. 27, 2012, and entitled “Rotating Locking MemberSuture Anchor and Method For Soft Tissue Repair”.

Although the suture locking member 706 is shown having a cam shape, theinvention is not so limited and the shape of the suture locking membermay vary widely.

Additionally, although the slot shown in this embodiment has a bottomand does not extend completely through the anchor wall, the inventionneed not be so limited. The slot may extend completely through theanchor body wall and the invention is only intended to be limited asrecited in the appended claims.

Methods for Tissue Repair

FIG. 11 is a flowchart showing the steps of a medical procedure forsecuring connective tissue to bone. This procedure includes the steps ofsecuring a first limb of a length of suture to a portion of connectivetissue to be attached to a portion of bone, using any method deemedsuitable to the clinician (Step 910).

Step 920 states to loop the length of suture through a lumen in a bodyof a suture anchor device and about a suture locking wedge disposedalong the length of the lumen.

The suture anchor device may be temporarily attached to an insertioninstrument shaft distal end, having an opening to provide a passage forthe length of suture to gain access to the suture anchor device asdescribed in previous figures. The shaft distal end may also have adriver to deploy an anchoring element, disposed at the proximal end ofthe anchoring device.

Next, the suture anchor is inserted into a portion of bone, deep enoughso that the anchor device proximal end is in the cancellous bone region.A marker or indicator may be present on the shaft distal end to aid inproper anchor placement. The suture anchor is then deployed to fix theanchoring portion or anchoring element in surrounding bone (930).

Step 940 states to apply tension to the second limb of the length ofsuture, such that the length of suture slides around the suture lockingwedge, so as to draw the first limb of the length of suture toward thesuture anchor device, thereby drawing the connective tissue closer tothe anchor thereby securing the portion of connective tissue snugly tothe portion of bone.

Step 950 states to move the suture locking wedge to a first suturelocking position, thereby compressing the suture at a first contactlocation between the suture locking wedge and the anchor body. Themovement preferably comprises rotation and translation.

This step may be carried out by modifying the tension on the second limb(e.g., pausing, adjusting, or releasing tension on the free limb) so asto allow the tension on the tissue bound end to move the suture lockingwedge.

Should the connective tissue need to be relocated, tension may beincreased to the second length of suture (e.g., the free limb),sufficient enough to move the suture locking wedge so as to increase thegap and allow the length of suture to slide around the suture lockingwedge, such that the soft tissue may be re-positioned relative to theportion of bone. After the connective tissue has been relocated, thetension may then be increased to the first limb of the length of sutureagain, so as to compress the suture again. The insertion instrument maythen be removed from the area.

In another embodiment the step of applying tension on the second limb ofthe suture to unseat the suture locking wedge is performed subsequent tostep 950 to release the suture from being compressed.

In another embodiment the method further comprises repeating steps 940and 950 to reposition the soft tissue and to re-tension the suture.Applying tension may be performed by pulling on the second limb of thesuture by hand or otherwise.

FIG. 12 illustrates a method for repairing capsular tissue. As shown, aglenoid section 1320 of a shoulder joint includes capsular tissue 1310.The capsular tissue 1310 serves to hold the humeral head in the shoulderjoint. It should not be loose. However, if the capsular tissue isstretched (e.g., due to injury) the shoulder becomes loose. This isundesirable.

Repairing the capsule may be performed by stitching folds in the capsuleto shrink its effective size (namely, plication). Tightening the capsuleto the proper degree makes the shoulder more stable. Folds may bestitched in various manners. In one embodiment, and with reference toFIG. 12, a method comprises securing a first limb of a suture 1312 to afirst anchor 1314.

A second limb of the suture 1312 is threaded or looped through a secondanchor 1316. The anchors may have features similar to the anchorsdescribed herein. In the anchors shown in FIG. 12, radially deflectablemembers 1322 fix the anchor to the tissue.

Next, the first anchor 1314 and second anchor 1316 are placed in thetissue 1310 and connected with suture 1312. FIG. 12 shows the anchorsseparated by a region. Suture 1312 can be tightened incrementally bypulling on free suture limb or tail 1318. The amount of tension appliedto the suture 1312 decreases the size of the region, tightening thecapsule tissue 1310. This affects the stability and range of motion inthe joint. The method thus allows the surgeon to increase tensions untila suitable stabilization is achieved that does not affect range ofmotion.

FIG. 13 illustrates another method for repairing soft tissue and inparticular, a method for repairing a radial tear 1342 in the lateralmeniscus 1330 of a knee.

Initially, the method comprises securing a first limb 1332 of a lengthof suture to a first anchor 1340 a.

Next, the suture is looped or threaded through additional anchors 1340b, 1340 c, 1340 d, and 1340 e such that a free suture limb 1336 extendsfrom the last-threaded anchor. In the embodiment shown in FIG. 13,anchor 1340 e is the last anchor of the sequence of anchors and freesuture limb 1336 is shown extending therefrom. Although five anchors areshown in FIG. 13, the number may vary. In a preferred embodiment, thenumber of anchors placed ranges from 2-10. Generally, fewer anchorswould preferably, but not necessarily, be deployed to close a smallertear. More anchors (e.g., 6 or more) would preferably, but notnecessarily, be deployed to close a larger tear.

Next, anchors 1340 a, b, c, d, e are placed, one at a time, in thetissue such that the suture length extending between any two anchorbodies spans the tear. For example, anchor 1340 b is next or adjacent insequence to 1340 a and the suture portion 1332 between the anchors 1340a and 1340 b is shown spanning tear 1342.

Next, the physician pulls on the free suture limb 1336. This step placestension on the suture spanning the tear 1342, closing the tear so thatit may heal.

Other modifications and variations can be made to the disclosedembodiments without departing from the subject invention. For example,other methods for anchor deployment will be apparent to the skilledartisan. Moreover, the instruments and methods described herein may beutilized in other regions of the body (e.g., knee, hip, etc.) and forother tissue treatment procedures. Thus, while the exemplary embodimentshave been described in detail, by way of example and for clarity ofunderstanding, a variety of changes, adaptations, and modifications willbe obvious to those of skill in the art. Therefore, the scope of thepresent invention is limited solely by the appended claims.

What is claimed is:
 1. An anchor device for repairing soft tissue with asuture, comprising: an anchor body comprising a wall, and the walldefining a lumen; and a suture locking wedge movably disposed within thelumen and engaged with the wall of the anchor body such that the suturelocking wedge may move with a first degree of freedom and a seconddegree of freedom with respect to the lumen and such that when a firsttension force is applied to a tissue limb of the suture extendingthrough the anchor body and looped around the suture locking wedge, thesuture locking wedge is urged into a suture locking position in whichthe suture is compressed between the suture locking wedge and a firstcontact location of the anchor body; and wherein the suture lockingwedge has an elongate cross section that is moved from a more parallelorientation towards a more perpendicular orientation relative to anelongate axis of the anchor body when urged to the suture lockingposition.
 2. The anchor device of claim 1 wherein the first degree offreedom is rotation.
 3. The anchor device of claim 2 wherein therotation is about an axis perpendicular to the longitudinal axis of theanchor device.
 4. The anchor device of claim 3 wherein the second degreeof freedom is translation in a direction parallel to the longitudinalaxis.
 5. The anchor device of claim 1 wherein said anchor body furthercomprises a bone fixation structure for securing the anchor device inthe bone wherein the bone fixation structure is selected from the groupconsisting of threads, ridges, barbs, and wings.
 6. The anchor device ofclaim 1 further comprising a gap between the suture locking wedge andthe first contact location of the anchor body such that the suturelocking wedge remains substantially free floating when not in the suturelocking position.
 7. The anchor device of claim 6 further comprising aflexible tether extending between the suture locking wedge and theanchor body.
 8. The anchor device of claim 1 wherein the anchor bodycomprises an elastic section which deforms when the suture locking wedgeis placed in the suture locking position.
 9. The anchor device of claim1 wherein the suture locking wedge and the lumen of the anchor body havecomplimentary engaging surfaces such that when the suture locking wedgeis urged into the suture locking position, the suture locking wedgecompresses the suture at a second contact location of the anchor body inaddition to the first contact location.
 10. The anchor device of claim 9wherein the first contact location and the second contact location areon opposite walls of the lumen.
 11. The anchor device of claim 1 whereinthe suture locking wedge comprises a first arm and a second arm, thefirst arm having a different length than the second arm.
 12. The anchordevice of claim 1 wherein the suture locking wedge is movably disposedwithin the anchor body such that when a second tension force is appliedto a free limb of the suture the suture locking wedge is urged away fromthe first contact location such that the suture is not compressed andcan slide freely around the suture locking wedge.
 13. An anchor devicefor repairing soft tissue with a suture, the anchor device comprising:an anchor body comprising an inner wall wherein the inner wall defines alumen, and said inner wall further defines at least one window; and asuture locking wedge rotatably and translatably movable within the lumenand engaged with the at least one window of the anchor body such thatthe suture locking wedge is movable between a first position and asecond position, and such that when a tension force is applied to atissue limb of the suture extending through the anchor body and loopedaround the suture locking wedge, the suture locking wedge is urged intothe first position in which the suture is compressed between the suturelocking wedge and a first contact location of the anchor body; andwherein the suture locking wedge has an elongate cross section definingan approximately uniform width and an elongate cross section axis thatis moved from a more parallel orientation towards a more perpendicularorientation relative to an elongate axis of the anchor body when urgedto the first position.
 14. The anchor device of claim 13 wherein thesuture locking wedge comprises at least one extension member extendinglaterally from an edge of the suture locking wedge and sized tointerface with the at least one window.
 15. The anchor device of claim13 wherein the suture locking wedge comprises two substantially planarsurfaces which contact the suture.
 16. The anchor device of claim 13wherein the suture locking wedge has a height that is less than or equalto ½ the diameter of the suture.
 17. The anchor device of claim 14wherein said at least one extension member comprises a plurality ofpins.
 18. The anchor device of claim 13 wherein the at least one windowcomprises a plurality of regions.
 19. The anchor device of claim 18wherein the plurality of regions comprises a first region correspondingto the suture locking wedge in the first position and a second regionoverlapping with the first region and corresponding to the suturelocking wedge in the second position.
 20. The anchor device of claim 19wherein the first region has a trapezoidal shape.
 21. The anchor deviceof claim 20 wherein the first region comprises a first distal flatsection which forms a first suture locking wedge angle with a radialaxis of the anchor device, and said first suture locking wedge angleranges from 15 to 30 degrees.
 22. The anchor device of claim 21 whereinthe second region comprises a second distal flat section which forms asecond suture locking wedge angle with the radial axis of the anchordevice, and said second suture locking wedge angle ranges from 5 to 15degrees less than the first suture locking wedge angle.
 23. The anchordevice of claim 22 wherein second suture locking wedge angle is about 15degrees.
 24. The anchor device of claim 13 wherein the suture lockingwedge comprises an elastic section which deforms when the suture lockingwedge is placed in the first position.
 25. The anchor device of claim 13wherein the suture locking wedge and the anchor body have complimentaryengaging surfaces such that when the suture locking wedge is urged intothe first position, the suture locking wedge compresses the suture at asecond contact location of the anchor body in addition to the firstcontact location.
 26. The anchor device of claim 25 wherein the firstcontact location and the second contact location are on opposite wallsof the lumen.
 27. The anchor device of claim 13 wherein the anchordevice comprises only two discrete parts not including the suture. 28.The anchor device of claim 13 wherein the at least one window isuncovered.
 29. The anchor device of claim 13 further comprising aflexible tether extending between the suture locking wedge and theanchor body.
 30. The anchor device of claim 13 wherein the anchor bodyand the suture locking wedge cooperate to translate in addition torotate.
 31. The anchor device of claim 13 wherein the suture lockingwedge is movably disposed within the anchor body such that when a secondtension force is applied to a free limb of the suture the suture lockingwedge is urged away from the first contact location such that the sutureis not compressed.